Process Engineer, Person-In-Plant

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

Uniquely Differentiated. Rapid. Elegant

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

About the Position

The Process Engineer, Person-In-Plant is responsible for supporting ongoing clinical and future commercial manufacturing activities (CDMOs), ensuring process reliability and optimization within our operations. The ideal candidate will work closely with cross-functional teams, including Manufacturing, Quality, Process Development, and Supply Chain, to drive continuous improvements in manufacturing performance. Travel Requirement: Must be willing to travel to corporate headquarters in Philadelphia for continuous training within the first 6 months.

Responsibilities:

• Main Responsibilities
• Provide “Person-in-Plant” (PIP) support and oversight of CART drug product manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs)

• • Oversight to ensure production runs smoothly.
  • Real-time troubleshooting of issues that arise during manufacturing.
  • Support CDMO manufacturing operator training program.
  • Lead manufacturing related deviation investigations and CAPAs across the network.
  • Establish network business process for root cause analysis suing established methodologies.
  • Support data capture of manufacturing production through excel and other data software.
  • Perform comprehensive manufacturing data analysis and trending.
  • Identify and support continuous improvement efforts between Cabaletta and the CDMO.
  • Review of batch records and other documentation to support product release activities.
  • Support drafting documentation that will be supplied to the CMO which includes but not limited to: Batch Records, Work Instructions, forms and Memos.
  • Support and review CDMO documentation from draft to finalization.
  • Support any pre- clinical runs which could include verification runs, pilot runs and engineering runs at the CDMO

• Secondary Responsibilities
• Collaborate closely with Process Development, Analytical Development and Quality and provide technical expertise to successful resolution of technical issues and process improvements
• Participate in technology transfer projects to CDMOs
• Participate in/lead risk management exercises, develop and document process FMEAs
• Preparation for and oversight of process performance qualification (PPQ) runs. Authoring of PPQ protocol and reports
• Authoring of relevant sections of regulatory filings and preparing responses to regulatory requests for additional information

Qualifications:

• Experience of using cell processing related equipment, such as CliniMACS Prodigy, Sepax C-Pro, LOVO cell processing system, and Xuri bioreactor.
• Familiarity with Lean and Six Sigma methodologies
• Ability to work off-shift, weekends and long hours as needed.
• Ability to lift over 30 lbs.
• Standing or sitting for long hours.

• Strong understanding and application of Lean manufacturing principles.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.  
• Experience of process validation lifecycle approach and risk assessments using a variety of tools, e.g., FMEA.
• Highly organized and efficient, strong team orientation and passion for continuous self-development.
• Ability to manage and coordinate parallel tasks across multiple projects, prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Experience contributing to preparation of documents for regulatory review, including but not limited to, INDs and BLAs.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-HYBRID